Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telik
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Are a woman 18 years of age or older

• Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer

• Have platinum refractory or resistant cancer

• Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

• Had treatment with first-line chemotherapy other than a platinum-containing regimen

• Have clinically significant cardiac disease

• Have any sign of intestinal obstruction interfering with nutrition

• Are pregnant or lactating

• Had prior treatment with liposomal doxorubicin

• Had prior treatment with Telcyta